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Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

Primary Purpose

Dysphagia Following Cerebrovascular Accident

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
home based IOPI swallow training
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia Following Cerebrovascular Accident focused on measuring dysphagia, ischemic stroke, intracranial hemorrhage

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities Mini-Mental Status Examination >20, could cooperate swallow therapy Exclusion Criteria: Already known dysphagia before stroke event Malocclusion or severe facial palsy Localized oral lesion interfering swallowing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Iowa Oral Performance Instrument (IOPI) training group

    controlled group

    Arm Description

    Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) and home- IOPI based resistance training

    Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only

    Outcomes

    Primary Outcome Measures

    Anterior tongue pressure
    Posterior tongue pressure
    Right buccal pressure
    Left buccal pressure
    Labial pressure

    Secondary Outcome Measures

    The score of Eat-10 scale

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    March 5, 2023
    Sponsor
    Taichung Veterans General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05758350
    Brief Title
    Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
    Official Title
    Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2023 (Anticipated)
    Primary Completion Date
    May 30, 2024 (Anticipated)
    Study Completion Date
    May 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taichung Veterans General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Iowa oral performance instrument (IOPI) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. In this study, we use Videofluoroscopic Swallowing Study (VFSS) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. They then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. Various tongue strength variables and subjective scale were obtained before and after the intervention. The purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia Following Cerebrovascular Accident
    Keywords
    dysphagia, ischemic stroke, intracranial hemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Iowa Oral Performance Instrument (IOPI) training group
    Arm Type
    Experimental
    Arm Description
    Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) and home- IOPI based resistance training
    Arm Title
    controlled group
    Arm Type
    No Intervention
    Arm Description
    Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only
    Intervention Type
    Behavioral
    Intervention Name(s)
    home based IOPI swallow training
    Intervention Description
    Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.
    Primary Outcome Measure Information:
    Title
    Anterior tongue pressure
    Time Frame
    1 week after treatment
    Title
    Posterior tongue pressure
    Time Frame
    1 week after treatment
    Title
    Right buccal pressure
    Time Frame
    1 week after treatment
    Title
    Left buccal pressure
    Time Frame
    1 week after treatment
    Title
    Labial pressure
    Time Frame
    1 week after treatment
    Secondary Outcome Measure Information:
    Title
    The score of Eat-10 scale
    Time Frame
    1 week after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities Mini-Mental Status Examination >20, could cooperate swallow therapy Exclusion Criteria: Already known dysphagia before stroke event Malocclusion or severe facial palsy Localized oral lesion interfering swallowing
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    CHUN MING FU
    Phone
    (886)04-2359-2525
    Ext
    3535
    Email
    jimmyrehab@vghtc.gov.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27606268
    Citation
    Lee JH, Kim HS, Yun DH, Chon J, Han YJ, Yoo SD, Kim DH, Lee SA, Joo HI, Park JS, Kim JC, Soh Y. The Relationship Between Tongue Pressure and Oral Dysphagia in Stroke Patients. Ann Rehabil Med. 2016 Aug;40(4):620-8. doi: 10.5535/arm.2016.40.4.620. Epub 2016 Aug 24.
    Results Reference
    background
    PubMed Identifier
    26834320
    Citation
    Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
    Results Reference
    background
    PubMed Identifier
    30693627
    Citation
    Park HS, Oh DH, Yoon T, Park JS. Effect of effortful swallowing training on tongue strength and oropharyngeal swallowing function in stroke patients with dysphagia: a double-blind, randomized controlled trial. Int J Lang Commun Disord. 2019 May;54(3):479-484. doi: 10.1111/1460-6984.12453. Epub 2019 Jan 28.
    Results Reference
    background
    PubMed Identifier
    27883209
    Citation
    Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
    Results Reference
    result

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    Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

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